Mark Shapiro featured in Outsourcing Pharma FDA Guidance on Risk-Based Trial Monitoring Story

By Emily Nichols / August 12, 2013

New York-based editor Zachary Brennan of Outsourcing Pharma recently spoke with our own Executive Director of Clinical Development, Mark Shapiro, to discuss the FDA’s finalized guidance on risk-based trial monitoring and why CROs and sponsor have not necessarily moved faster towards remote and central monitoring.

As Mark points out in the article, he was not “surprised that there was a call to move away from on-site monitoring. This is because everyone has tended to lay the huge cost of trails on the cost of 100% SDV [site data verification] through on-site monitoring.”

The US FDA has finalized guidance on clinical trial oversight, calling for more remote and targeted risk-based monitoring, though some experts believe such monitoring should be more judiciously employed.

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